Status:
UNKNOWN
SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma
Lead Sponsor:
Aiping Zhou
Conditions:
HER2-positive
Locally Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gas...
Detailed Description
This phase II trial is a single-arm and single-center clinical study. Neoadjuvant chemotherapy is a standard treatment for locally advanced gastric cancer. The SOX regimen has became the standard peri...
Eligibility Criteria
Inclusion
- Sign the informed consent form.
- Locally advanced adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III) confirmed by pathology or cytology.
- The definition of a positive HER2 test result is as follows: IHC detects HER2 3+ or IHC detects HER2 2+ and FISH is positive.
- Clinically, based on chest, abdomen and pelvic CT, gastroscopy, endoscopic ultrasonography, gastrointestinal contrast, ordinary ultrasound, or laparoscopy if possible, it is judged as T3-4a N+ or T4bN any gastric cancer or gastroesophageal junction cancer (refer to AJCC Article Version 8 in stages).
- Patients have not received chemotherapy and/or immunotherapy and/or trastuzumab treatment and/or radiotherapy in the past.
- Age 18-75 years old.
- The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, and there was no deterioration within 2 weeks before the first administration of the study drug.
- Good organ function:
- Blood routine: hemoglobin ≥90g/L, white blood cell ≥3.0×109/L, neutrophil ≥1.5×109/L, platelet ≥100×109/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥60ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL.
Exclusion
- The pathology is other types besides adenocarcinoma, such as squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma and so on.
- Have received chemotherapy and/or radiotherapy in the past.
- Have received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies and other immunotherapy in the past.
- Have received any anti-HER2 therapy in the past.
- Intra-abdominal dissemination or distant metastasis (M1).
- Clinically significant ascites.
- Known to have allergic reactions to oxaliplatin and any ingredients or excipients of Tiggio.
- Known to have allergic reactions to any ingredients or excipients of Sintilimab and Trastuzumab.
- Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05218148
Start Date
April 1 2022
End Date
December 1 2025
Last Update
April 6 2022
Active Locations (1)
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1
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, China, 100021